Latest Headlines
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GenomOncology Introduces Expanded Support For Germline Testing In GO Pathology Workbench
4/29/2024
GenomOncology (GO) revealed today an upgraded version of GO Pathology Workbench, their software platform for tertiary analysis and reporting of next generation sequencing (NGS) and other molecular testing results.
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Labcorp Receives FDA Approval For First Companion Diagnostic For Use With Pfizer's Newly Approved Gene Therapy To Treat Patients With Hemophilia B
4/29/2024
Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced the U.S. Food and Drug Administration (FDA) has approved its nAbCyte™ Anti-AAVRh74var HB-FE Assay, a companion diagnostic (CDx) to determine patient eligibility for treatment with BEQVEZ™ (fidanacogene elaparvovec-dzkt), Pfizer's recently FDA-approved hemophilia B gene therapy.
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The Association For Diagnostics & Laboratory Medicine (Formerly AACC) Opposes FDA Ruling On Laboratory Developed Tests; Urges FDA To Involve All Stakeholders In Modernization Of Laboratory Developed Test Regulation In Order To Preserve Patient Access To V
4/29/2024
"We at the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) strongly disagree with the Food and Drug Administration's (FDA's) decision to issue a final rule placing laboratory developed tests under duplicative FDA authority, in addition to these tests' current regulation under the Centers for Medicare & Medicaid Services (CMS).
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FDA Takes Action Aimed At Helping To Ensure The Safety And Effectiveness Of Laboratory Developed Tests
4/29/2024
Today, the U.S. Food and Drug Administration took action aimed at helping to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health care decisions and about which concerns have been raised for many years.
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C2N Diagnostics Expands Into Japan Through Mediford Corporation Partnership With Precivity Blood Testing For Alzheimer’s Disease And Brain Research Market
4/26/2024
C₂N Diagnostics, LLC (“C2N”), a specialty diagnostics company with a vision to bring Clarity Through Innovation®, today announced a partnership agreement with Mediford Corporation, a PHC Holdings Corporation (TSE 6523) Group Company and premier provider of clinical research to the biopharma industry throughout Japan.
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Empowering Innovation: StatLab Welcomes Scientific Device Laboratory Into Family
4/25/2024
StatLab Medical Products (“StatLab”), a leading developer and manufacturer of medical diagnostic supplies and equipment, today announced the acquisition of Scientific Device Laboratory (“SDL”), a Chicago-based manufacturer of printed diagnostic slides and a variety of consumables and kits for the anatomic pathology and microbiology markets.
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Microbix Collaborator Introduces New Lab Accreditation Program
4/25/2024
Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that Labquality Ltd., a collaborator and customer, is presenting results of its use of Microbix Quality Assessment Products (“QAPs™”) for accreditation of clinical labs for conducting molecular (“MDx”) tests for antimicrobial-resistant (“AMR”) strains of M. genitalium (“Mgen”), a common sexually-transmitted infection (“STI”).
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Revvity Unveils A New Era Of Automated Tuberculosis Testing
4/24/2024
Revvity, Inc.today announced the launch of the Auto-Pure 2400 liquid handler from Allsheng for use with the T-SPOT.TB test. The Auto-Pure 2400 platform is easy to use and designed to provide efficient workflows in the lab.
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ARUP Partners With ELLKAY To Bring Connectivity Solutions To Health System Outreach Operations
4/24/2024
ARUP Laboratories and healthcare connectivity company ELLKAY have forged a new partnership aimed at helping health systems establish or expand successful laboratory outreach operations.
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Clarapath Forms Strategic Collaboration With Mayo Clinic To Advance Pathology Tissue Processing
4/23/2024
Clarapath, a medical robotics company transforming the way pathology laboratories process tissue, announced it has entered into a strategic collaboration with Mayo Clinic to propel a new era of laboratory automation.